MAGnetic marker TO detect primary lesion and sentinel node in breast cancer. The randomised MAGTOtal trial.

Not Applicable

Completed

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN11914537
• Lead Sponsor: ppsala University

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38150215/ (added 28/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-01
• Study Completion: 2022-02-01
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 426

Inclusion Criteria

1. Aged 18 years or older
2. Ductal carcinoma in situ (DCIS) or invasive breast cancer requiring localisation planned for primary surgery including sentinel node biopsy

Exclusion Criteria

1. Intolerance or hypersensitivity to iron or dextran compounds or Sienna XP
2. Iron overload disease
3. Pacemaker or other implantable device in the chest-wall, or prosthesis in the shoulder
4. Deprived of liberty or under guardianship
5. Pregnant or lactating
6. Inability to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radical excision, defined as free surgical margins of the specimen of the primary tumour according to preoperative diagnosis.

Secondary Outcome Measures

Name	Time	Method
1. Width of margins per study arm in mm from the tumour to the resection margin both on specimen radiology and on final pathology.<br>2. Operative time from the beginning of the breast operation until the excision of the specimen in minutes.<br>3. Intraoperative and postoperative complications on 30 days, described by the Clavien Dindo classification and the Comprehensive Complication Index (CCI) (www.assessurgery.com).<br>4. Cost/benefit analysis based on the expenses of inpatient and outpatient care regarding the operation and 30 days of the postoperative period.